Synthekine Partners with Merck to Evaluate STK-012 Combination Therapy in Phase 2 NSCLC Trial
核心洞察
Synthekine (搜索) has entered a clinical trial collaboration with Merck (搜索) to evaluate STK-012 in combination with Keytruda and chemotherapy for first-line PD-L1 (搜索) negative nonsquamous non-small cell lung cancer patients.
The global randomized Phase 2 SYNERGY-101 trial began enrolling patients in November 2025, with the first patient already dosed.
STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist designed to selectively stimulate antigen-activated T cells while avoiding broad lymphocyte stimulation associated with IL-2 toxicity.
Synthekine (搜索) Inc. has announced a clinical trial collaboration and supply agreement with Merck (搜索) to evaluate STK-012 in combination with Keytruda (pembrolizumab) and chemotherapy in patients with first-line, PD-L1 (搜索) negative nonsquamous non-small cell lung cancer (NSCLC). The partnership centers on the ongoing SYNERGY-101 randomized Phase 2 trial, which aims to assess the efficacy and safety of this combination therapy in a patient population that receives limited benefit from current standard of care treatments.
Novel Cytokine Therapy Shows Early Promise
STK-012 represents a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity. The therapy is designed to avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity.
"In our Phase 1b study, STK-012 in combination with pembrolizumab and chemotherapy has shown promising efficacy in first-line PD-L1 (搜索) negative NSQ NSCLC patients, with a 50% response rate in this population presented at the Society for Immunotherapy of Cancer Annual Meeting 2025," said Debanjan Ray, Chief Executive Officer of Synthekine (搜索).
SYNERGY-101 Trial Design and Objectives
The global, randomized SYNERGY-101 Phase 2 study began enrolling patients in November 2025, with the first patient already dosed. The trial will compare the combination of STK-012, standard dose pembrolizumab, and chemotherapy against standard dose pembrolizumab plus chemotherapy alone in patients with first-line, PD-L1 (搜索) negative nonsquamous NSCLC.
Under the collaboration agreement, Merck (搜索) will supply its anti-PD-1 (搜索) therapy Keytruda for inclusion in the study. Both companies retain all commercial rights to their respective compounds for future use in combination regimens or as monotherapies.
Addressing Unmet Medical Need
Ray emphasized the potential clinical impact for this patient population: "We are excited to collaborate with MSD on our randomized Phase 2 study to further demonstrate the potential of this combination to deliver improved clinical outcomes for these patients, who receive limited benefit from current standard of care therapies."
The collaboration builds on Synthekine (搜索)'s focus on developing selective immunotherapies using engineered cytokines to potentially improve treatment paradigms in inflammatory diseases and cancer. The SYNERGY-101 trial is registered at clinicaltrials.gov under the identifier NCT05098132.